摘要
目的:加深相关人员对《药品质量抽查检验管理办法》的理解,以有效地落实抽检规定,加强药品监管。方法:对比研究《药品质量抽查检验管理办法》和《药品质量抽查检验管理规定》中组织、抽样和收检要求,分析新增和修订内容的必要性与意义,提出实施建议。结果与结论:《药品质量抽查检验管理办法》基于药品监管需要,相对于《药品质量抽查检验管理规定》新增和修订的组织、抽样和收检相关内容,对加强抽检管理,提高抽样、收检工作效能,进而打击假冒伪劣药品,防控潜在质量安全隐患具有重要意义。
Objective:To provide references for deeply understanding the new regulation for drug sampling and testing to implement it more effectively and reinforce the drug supervision.Methods:To compare the organization,sampling and acceptance requirements of the new and old regulations,which were issued in August 2019 and July 2006,respectively,analyze the necessity and significance of their new and revised contents,and put forward the suggestions for implementation.Results and Conclusion:The new and revised contents of organization,sampling and acceptance have great value to reinforce the management of drug sampling and testing and improve the efficiency of sampling and acceptance,and then fight against the counterfeit and inferior drugs and the potential risk.
作者
刘文
王翀
朱炯
胡增峣
Liu Wen;Wang Chong;Zhu Jiong;Hu Zengyao(National Institutes for Food and Drug Control,Beijing 102629,China;National Medical Products Administration,Beijing 100037,China)
出处
《中国药事》
CAS
2020年第6期619-624,共6页
Chinese Pharmaceutical Affairs
关键词
药品抽检
组织
抽样
收检
drug sampling and testing
organization
sampling
acceptance
